JP2015523118A - Control for biopsy device - Google Patents

Abstract

An exemplary biopsy system includes a biopsy device having a probe. The probe includes a distally extending needle and a cutter that can move relative to the needle. The probe also includes a tissue specimen holder removably coupled to the proximal end of the probe. The biopsy system has a cycle in which the biopsy system applies a vacuum to the biopsy device, retracts the cutter to the proximal position, advances the cutter to the distal position, and transports the specimen to the tissue specimen holder. The biopsy system can adjust the duration of the cycle during operation of the biopsy device.

Description

Disclosure details

〔background〕
Biopsy specimens have been obtained in a variety of ways in a variety of medical procedures using a variety of devices. The biopsy device can be used under stereotaxic guidance, ultrasound guidance, MRI guidance, PEM guidance, BSGI guidance, or others. For example, some biopsy devices can be fully operated by a user with one hand and can capture one or more biopsy specimens from a patient with a single insertion. In addition, some biopsy devices include vacuum modules, for example, for communication of fluids (eg, pressurized air, saline, air, vacuum, etc.), for power transmission, and / or for communication such as commands. And / or connected to a control module. Other biopsy devices may be fully or at least partially operable without being connected or otherwise connected to another device.

  An merely exemplary biopsy device is disclosed below: US Pat. No. 5,526,822 issued Jun. 18, 1996 under the name “Method and Apparatus for Automated Biopsy and Collection of Soft Tissue”. No .; US Patent No. 6,086,544 issued on July 11, 2000 under the name “Control Apparatus for an Automated Surgical Biopsy Device”; September 11, 2003 under the name “MRI Compatible Surgical Biopsy Device” US Pat. No. 6,626,849 issued on the same day; US Pat. No. 7,442,171 issued Oct. 8, 2008 under the name “Remote Thumbwheel for a Surgical Biopsy Device”; “Clutch and US Patent No. 7,854,706 issued on Dec. 1, 2010 under the name “Valving System for Tetherless Biopsy Device”; issued on May 10, 2011 under the name “Vacuum Timing Algorithm for Biopsy Device” Published US Patent No. 7,938,786; US Patent Application Publication No. 2006/0074345 published April 6, 2006 under the name "Biopsy Apparatus and Method"; "Presentation of Biopsy Sample by Biopsy Device" US Patent Application Publication No. 2008/0214955 published on September 4, 2008 under the name of US Patent Application Publication No. 2008/0221480 published on September 11, 2008 under the name of “Biopsy Sample Storage” US Patent Application Publication No. 2009/0131821 published May 21, 2009 under the name “Graphical User Interface For Biopsy System Control Module”; 2009 under the name “Icon-Based Uswer Interface On Biopsy System Control Module” US Patent Application Publication No. 2009/0131820 published on May 21, 2009; “Hand Actuated Tetherless Biopsy Device with Pistol Grip” US Patent Application Publication No. 2010/0152610 published on June 17, 2010 by name; US Patent Application Publication No. 2010/0160819 published on June 24, 2010 by name of “Biopsy Device with Central Thumbwheel” No .; US Patent Application Publication No. 2010/0317997 published December 16, 2010 under the name “Tetherless Biopsy Device with Reusable Portion”; November 24, 2010 under the name “Handheld Biopsy Device with Needle Firing” No. 12 / 953,715 filed on April 14, 2011; US Non-Provisional Patent Application No. 13 / 086,567 filed April 14, 2011 under the name of “Biopsy Device with Motorized Needle Firing” A US non-provisional patent application 13 / 150,950 filed June 1, 2011 under the name "Needle Assembly and Blade Assembly for Biopsy Device" ; US Non-provisional Patent Application No. 13 / 205,189, filed August 8, 2011 under the name "Access Chamber and Markers for Biopsy Device"; "Biopsy Device Tissue Sample Holder with Bulk Chamber and Pathology Chamber" US non-provisional patent application No. 13 / 218,656 filed on August 26, 2011 by name; US provisional patent filed on December 5, 2011 under the name "Biopsy Device With Slide-In Probe" Application 61 / 566,793. The disclosures of each of the above listed US patents, US patent application publications, and US non-provisional patent applications are hereby incorporated by reference.

  Several systems and methods have been made and used to obtain biopsy specimens, but we believe that no one has made or used the claimed invention prior to the inventors.

  The specification concludes with claims that particularly point out and distinctly claim this technology, which is believed to be better understood from the following description of specific embodiments, taken together with the accompanying drawings. It is done. In the accompanying drawings, like reference characters identify the same elements.

  The drawings are not intended to be limiting in any way, and it is understood that various embodiments of this technology may be implemented in a variety of other ways, including those not necessarily depicted in the drawings. I am planning. The accompanying drawings, which are incorporated in and form a part of this specification, illustrate several aspects of the technology and, together with the description, serve to explain the principles of the technology, It will be understood that the invention is not limited to a strict configuration.

[Detailed explanation]
The following description of specific embodiments of this technology should not be used to limit its scope. Other examples, features, aspects, embodiments, and advantages of this technology will be apparent to those skilled in the art from the following description. The following description is, by way of example, one of the best practices contemplated for implementing this technology. As will be appreciated, the technology described herein is capable of other different and obvious aspects that do not depart from this technology. Accordingly, the drawings and descriptions are to be regarded as illustrative in nature, and not as restrictive.

I. Exemplary Biopsy System Overview FIG. 1 depicts an exemplary biopsy system (10) that includes a biopsy device (100), a plurality of conduits (400), and a control module (500). . The biopsy device (100) includes a holster (202) and a probe (102). The needle (110) extends distally from the probe (102) and is inserted into the patient's tissue to obtain a tissue specimen, as described in more detail below. These tissue specimens are deposited in a tissue specimen holder (302) that is coupled to the proximal end of the probe (102), also as described in more detail below. Of course, the needle (110) and the tissue specimen holder (302) can be coupled to the probe (102) at various ranges of locations. For example, the needle (110) may extend from the top of the probe (102), from the side of the probe (102), from the bottom of the probe (102), or may be omitted entirely from the probe (102). The tissue specimen holder (302) may be coupled to the top of the probe (102), to the side of the probe (102), to the bottom of the probe (102), or may be omitted entirely from the probe (102). . The probe (102) of this example is separable from the holster (202), but this is merely an option. The use of the term “holster” herein should not be read as necessarily requiring that any part of the probe (102) be inserted into any part of the holster (202). I want you to understand. The notched upper control unit (220) of the holster (202) and the latch (190) of the probe (102) cooperate as shown in FIGS. 2-4 and 7 and described in more detail below. The probe (102) is releasably secured to the holster (202), but various other types of structures, components, features, etc. (eg, bayonet mounts (bayonet It should be understood that mounts), protrusions, clamps, clips, snap fittings, etc. can be used to provide a removable connection between probe (102) and holster (202). Further, in some biopsy devices (100), the probe (102) and holster (202) may be of an integral or integrated structure so that the two components cannot be separated. ing. By way of example only, in a version where probe (102) and holster (202) are provided as separable components, probe (102) may be provided as a disposable component, and holster (202) is reusable. It may be provided as a component. Still other suitable structural and functional relationships between probe (102) and holster (202) will be apparent to those skilled in the art in view of the teachings herein.

  The biopsy system (10) shown in FIG. 1 further includes a control module (500) fluidly coupled to the biopsy device (100) via one or more conduits (400). In this example, the control module (500) includes a vacuum source (510) operable to provide a vacuum to the biopsy device (100). The control module (500) further includes a user interface (526) that allows a user to adjust the level of vacuum supplied to the biopsy device (100). It may be desirable for the user to adjust the vacuum level depending on the characteristics (hardness, thickness, etc.) of the tissue to be sampled by the biopsy device (100). The user interface (526) is discussed in further detail below. By way of example only, the vacuum source (510) is housed within the control module (500) and is fluidly coupled to the probe (102) by a first conduit (402) such as a flexible tube. Of course, additionally or alternatively, the vacuum source (510) can be incorporated into the probe (102), incorporated into the holster (202), and / or a completely separate component. One non-provisional patent application filed on Nov. 24, 2010 under the name “Handheld Biopsy Device with Needle Firing”, one exemplary biopsy device (100) incorporating a vacuum source (510). No. 12 / 953,715, the disclosure of which is hereby incorporated by reference. As shown in FIG. 1, the vacuum source (510) is in fluid communication with the probe (102) and with the needle (110), as will be described in more detail below. Thus, the vacuum source (510) can be actuated to draw tissue into the lateral hole (112) of the needle (110), described in more detail below. The vacuum source (510) is also in fluid communication with the tissue specimen holder (302) and the cutter (120). Thus, the vacuum source (510) of the control module (500) may be actuated to draw the cut tissue specimen through the cutter lumen (136) of the cutter (120) and into the tissue specimen holder (302). it can. Of course, other suitable configurations and uses of the vacuum source (510) will be apparent to those skilled in the art in view of the teachings herein. It should also be understood that the vacuum source (510) may simply be omitted if desired.

  In some versions, a vacuum source (510) is provided in accordance with the teachings of US Patent Application Publication No. 2008/0214955, published September 4, 2008, under the name “Presentation of Biopsy Sample by Biopsy Device” This disclosure is incorporated herein by reference. As yet another exemplary embodiment, the vacuum source (510) is the teaching of US Patent Application Publication No. 2011/0208086 published August 25, 2011 under the name "Biopsy Device with Auxiliary Vacuum Source". This disclosure is incorporated herein by reference. Still other suitable ways in which a vacuum source (510) may be provided will be apparent to those skilled in the art in view of the teachings herein.

A. Exemplary Control Module and Conduit The control module (500) of this example is further fluidly coupled to the biopsy device (100) by a second conduit (404) such as a flexible tube and a third conduit (406). However, one or both of these conduits can be omitted. The third conduit (406) is in fluid communication with the saline bag (410) by the control module (500). The saline bag (410) contains a saline fluid, but other fluids, gels, solids suspended in the fluid, as will be apparent to those skilled in the art in view of the teachings herein. It should be understood that and / or other fluidic materials can be used. Of course, it should be understood that the saline bag (410) may be directly coupled to the third conduit (406) and / or the biopsy device (100). Further, in some versions, the third conduit (406) is not coupled to the control module (500), but is a syringe (not shown) or other device for delivering fluids, medications, and / or other items. A luer lock end (not shown) may be included instead, to which items can be coupled. The second conduit (404) is also fluidly coupled to the control module (500) and provides a filtered atmosphere to the biopsy device (100) by a filter (not shown) of the control module (500). Similar to the third conduit (406), in some versions, the second conduit (404) is not coupled to the control module (500), but instead is a luer lock end (not shown) or a filter ( (Not shown). In this example, the second conduit (404) and the third conduit (406) are coupled together by a connector (408) before being coupled to the probe (102). The connector (408) seals either the second conduit (404) or the third conduit (406) while the other conductor (404, 406) is in fluid communication with the probe (102). In addition, a valve may be included. Of course, in other versions, the connector (408) is a Y-shaped connector so that both the second conduit (404) and the third conduit (406) can be coupled to the probe (102). May be included.

  In some versions, the conduit (400) can be retracted into the control module (500) when the first, second and / or third conduit (402, 402, 406) is not in use. It can be coupled to the retraction system (520) of the control module (500). By way of example only, the retraction system (520) may include one or more spring-loaded spools (522), each of the first, second, and / or third conduits (402, 404). , 406) is wound around the spool (522). The spool (522) may be coupled to a ratchet assembly (not shown), and when the user pulls the conduit (402, 404, 406), the ratchet assembly causes the spring-loaded spool to be connected to the conduit (402, 404, 406). 406) is prevented from retracting. A retract button (524) is mounted on the casing of the control module (500) and is operable to release the ratchet assembly to retract the conduits (402, 404, 406). Additionally or alternatively, the spool (522) may be coupled to a hand crank (not shown) to manually retract the conduit (402, 404, 406) around the spool (522). In some versions, the retraction button (524) is operated from the biopsy device (100), for example by the button (228) of the notched upper control unit (220), while the user is using the device. The conduits (402, 404, 406) can be retracted. By way of example only, a button (not shown) on the biopsy device (100) can actuate a solenoid to release the ratchet assembly. Thus, the user can remove the amount of potential tangling and / or any extra conduit (402, 404, 406) around where the user is using the biopsy device (100). Can be reduced. Additionally or alternatively, such remote retraction can be selectively braked or controlled (by either a brake or motor) to slowly retract the conduit (402, 404, 406). Can be done. Such slow retraction can prevent the conduit (402, 404, 406) from quickly retracting and pulling the biopsy device (100) from the user's hand.

  Although the conduits (402, 404, 406) are illustrated as separate conduits, the conduits (402, 404, 406) are a single tube that is subdivided into any number of suitable conduits. It should be understood that they can be combined. In some versions, the conduits (402, 404, 406) can be fused together lengthwise to form a rectangular integral three-conduit tube. Of course, further configurations of the conduits (402, 404, 406) will be apparent to those skilled in the art in view of the teachings herein. In some versions, the conduit (402, 404, 406) may not retract, or only a portion of the conduit (402, 404, 406) may retract. In such a configuration, the conduit (402, 404, 406) is separable from a connector (not shown) operable to be coupled to one or more sockets (not shown) of the control module (500). It may be. Thus, after the conduit (402, 404, 406) is used for treatment, the conduit (402, 404, 406) can be disconnected from the connector and disposed of. New conduits (402, 404, 406) may be coupled to the connector for the next procedure. In just one exemplary configuration, the reusable conduit portion may be coupled to a disposable conduit portion. The reusable conduit portion of this embodiment can be coupled to the retraction system (520). Accordingly, the reusable conduit portion may have a predetermined size, such as 1.52 meters (5 feet), and the one or more disposable conduits are coupled to the reusable conduit portion to treat Various lengths of conduit can be provided for. When the procedure is over, the disposable conduit segment is disposed of and the reusable conduit segment is retracted into the control module (500) for storage. Additionally or alternatively, the retraction system (520) and conduits (402, 404, 406) are as selectively insertable devices that can be inserted into or removed from the control module (500). Can be built. By way of example only, such a selectively insertable retraction system (520) was issued on May 10, 2011 under the name “Vacuum Timing Algorithm for Biopsy Device”, the disclosure of which is incorporated herein by reference. Can be constructed in the same manner as the vacuum canister described in U.S. Pat. No. 7,938,786. Thus, in some versions, the entire retraction system (520) may be disposable, or in some versions it may be recyclable to be sterilized again for reuse.

  In this embodiment, a power cord (420) extends from the vacuum control unit (500) to electrically connect and power the biopsy device (100). The power cord (420) may be configured to supply DC or AC power to the biopsy device (100). Additionally or alternatively, the power cord (420) can be operable to transmit data between the control module (500) and the biopsy device (100). The power cord (420) includes an end connector (not shown) configured to be selectively coupled to the end connector (298) of the cable (290) shown in FIGS. Thus, the power cord (420) of the control module (500) may be separable from the holster (202), each of which can be stored separately, but this is merely an option. The power cord (420) of this embodiment is also coupled to a spring loaded spool (522) that can be retracted by the retracting system (520) described above. It should be understood that the spool (522) to which the power cord (420) is coupled may be a separate spool from the spool for the conduits (402, 404, 406). Further, the retraction system (520) for the spool (522) to which the power cord (420) is coupled may also be a separate retraction system. For example, the control module (500) may have a removable retraction system (520) for the conduits (402, 404, 406) that can be removed and disposed of while the permanent retraction system (520). ) Is provided for the power cord (420). Of course, some versions of the biopsy device (100) may be powered internally so that the power cord (420) can be omitted. In some versions, the spool (522) is a single having a plurality of separate spools such that the conduit (402, 404, 406) and the power cord (420) are retracted and extended simultaneously and at the same speed. Of spools. In some versions, the power cord (420) may be incorporated into the singular tube conduit described above, with three subdivisions for fluid flow and one subdivision transmitting power. Extending from the vacuum control unit (500) is a single cord having Additional configurations of power cord (420), control module (500), and / or retraction system (520) will be apparent to those skilled in the art in view of the teachings herein.

B. Overview of Exemplary Biopsy Device The biopsy device (100) of this example is configured to be held by a user with respect to a patient and guided by an ultrasound imaging device. Of course, the biopsy device (100) may alternatively be used under stereotaxic guidance, MRI guidance, PEM guidance, BSGI guidance, or others. It should also be understood that the biopsy device (100) can be sized and configured so that the user can operate the biopsy device (100) with one hand. Specifically, the user can grab the biopsy device (100), insert the needle (110) into the patient's breast, and take one or more tissue samples from within the patient's breast. All with one hand. Alternatively, the user can grab the biopsy device (100) with two or more hands and / or with any desired help. In some circumstances, the user can capture multiple tissue specimens with a single insertion of the needle (110) into the patient's breast. Such tissue specimens can be pneumatically deposited in the tissue specimen holder (302) and later retrieved from the tissue specimen holder (302) for analysis. Although the embodiments described herein often refer to obtaining biopsy specimens from a patient's breast, the biopsy device (100) may be used for a variety of other purposes, and for patient anatomy. It should be understood that a variety of other procedures (e.g., prostate, thyroid, etc.) can be used in a variety of other procedures. Various exemplary components, features, configurations, and operability of the biopsy device (100) are described in further detail below, but other suitable components, features, configurations, and operability are described. In view of the teachings herein, it will be apparent to those skilled in the art.

  The biopsy device (100) of the present embodiment includes a separable probe (102) and a holster (202) as shown in FIGS. In this example, the probe (102) initially slides sideways onto the holster (202) until the distal probe portion (120) enters and contacts a portion of the notched upper control unit (220). The probe (102) is then slid distally to secure the probe (102) to the holster (202). Once slid distally, the latch (190) of the probe (102) engages the latch member (238) of the holster (202) to securely couple the probe (102) to the holster (202). The tissue can then be cut and transported proximally into the tissue specimen holder (302). Biopsy device (100) and tissue specimen holder (302) are described in US Pat. No. 7,938,786, issued May 10, 2011 under the name “Vacuum Timing Algorithm for Biopsy Device”; US Patent Application Publication No. 2008/0221480 published on September 11, 2008 under the name of "Tetherless Biopsy Device with Reusable Portion" 2010/0317997; US Non-Provisional Patent Application No. 12 / 953,715 filed November 24, 2010 under the name “Handheld Biopsy Device with Needle Firing”; under the name “Biopsy Device with Motorized Needle Firing” US Non-Provisional Patent Application No. 13 / 086,567, filed April 14, 2011; and / or “Access Chamber and Markers for Biopsy Device” May be further constructed in accordance with at least some of the teachings of US Non-Provisional Patent Application No. 13 / 205,189, filed Aug. 8, 2011, the disclosures of which are hereby incorporated by reference. . Of course, further configurations of the biopsy system (10) will be apparent to those skilled in the art in view of the teachings herein.

II. The exemplary holster (202) includes an upper housing cover (210), a housing base (260), and a cable (290). Cable (290) includes a plurality of wires (292) as shown in FIG. 6 to provide power and / or control signals to various components housed within housing base (260). The cable (290) further includes an end connector (298) operable to selectively couple the holster (202) to the connector of the power cord (420) described above, or in some versions, The end connector (298) may be directly connectable to the control module (500). The housing base (260) includes a biocompatible and rigid plastic material, such as polycarbonate, which is molded to include an upwardly bent distal arcuate portion (262) as shown in FIGS. The housing base (260) may be positioned near the patient's body during use. By way of example only, the arcuate portion (262) may be configured such that a portion of the patient's anatomy, such as the chest or other portion of the patient's rib cage, at least partially defines a curved cavity formed by the arcuate portion (262). The biopsy device (100) can be easily positioned in various orientations near the patient's body. By way of example only, the configuration of the arcuate portion (262) may allow more access to the patient's breast compared to that otherwise provided by a generally rectangular or cylindrical biopsy device. The arcuate portion (262) extends proximally over about one fifth of the length of the holster (202), but this is merely an option. In some versions, the arcuate portion (262) can extend proximally over about half, less than half, or more than half of the longitudinal length of the holster (202). Additionally or alternatively, the arcuate portion (262) includes a padded portion (not shown), such as a gauze pad, so that the arcuate portion (262) when the arcuate portion (262) contacts the patient's skin. Can reduce the “mechanical” feel. Further configurations of the arcuate portion (262) will be apparent to those skilled in the art in view of the teachings herein.

  Referring now to FIGS. 3-4, the upper housing cover (210) is also formed of a biocompatible and rigid plastic material, such as polycarbonate, with a notched upper control unit (220), gear slot (230). ), Intermediate rail (240), front rail (242), latch member (238), and gear hole (250). As best seen in FIG. 3, the holster gear (272) is exposed through the gear hole (250) and the probe gear of the probe (102) when the probe (102) is coupled to the holster (202). (170). Accordingly, rotation of the holster gear (272) rotates the probe gear (170) to drive the cutter actuation assembly (150) of the probe (102), which will be described in more detail below. The gear slot (230) is a recess in the upper housing cover (210) configured to move the probe gear (170) along the gear slot (230) when the probe (102) slides over the holster (202). It is a concave portion. The gear slot (230) includes a lateral portion (232) and a longitudinal portion (234). Thus, when the probe (102) is coupled to the holster (202), the probe gear (170) first enters the lateral portion (232), and the probe (102) is substantially longitudinal with the holster (202). Move along the transverse slot (232) until aligned. Once the probe (102) is longitudinally aligned with the holster (202), the probe (102) is pushed forward by the user until the probe gear (170) engages the holster gear (272). ) Within the longitudinal portion (234) of the gear slot (230). Of course, the gear slot (230) is merely optional and may be omitted. Additionally or alternatively, a similar gear slot (not shown) may be formed at the bottom of the probe (102).

  As the probe (102) slides distally, the intermediate slot (108) of the probe (102) slides over the intermediate rail (240) of the top cover (210), and the front slot (128) becomes the front rail (242). Slide up. The combination of the intermediate slot (108), the intermediate rail (240), the forward slot (128), and the forward rail (242) provides further alignment for coupling the probe (102) to the holster (202). . Furthermore, the rails (240, 242) are such that once the probe (102) is coupled to the holster (202), the rails (240, 242) resist lateral displacement of the probe (102) relative to the holster (202). Can also be sized. Of course, further configurations of rails (240, 242) and slots (108, 128) will be apparent to those skilled in the art in view of the teachings herein.

  The notched upper control unit (220) extends from the first surface of the top cover (210), initially upward and then inward, thereby providing an inverted L-shaped component having an overhang (222). Forming. In the illustrated embodiment, the notched upper control unit (220) includes an upwardly extending portion (224) connected to the overhang (222), thereby moving the probe (102) relative to the holster (202). An upper boundary is formed for fixing. Thus, even if the biopsy device (100) is reversed or positioned in any other orientation, the overhang (222) will contact the holster (202) and the probe (102) Hold. Furthermore, the notched upper control unit (220) increases the height of the holster (202), but it is hereby noted that the width of the holster (202) is reduced by providing the upper control unit (220). Will be understood by those skilled in the art in view of the teachings herein. Thus, this narrow width allows the user to hold the holster (202) and / or assembly biopsy device (100) in the same way as holding a pencil or other object with a thin body. Can be grabbed.

  The notched upper control unit (220) further includes a control panel (226) having a plurality of buttons (228). In this example, the button (228) includes a rocker button (228a), a first button (228b), and a second button (228c). In this example, the second button (228c) is operable to selectively activate the biopsy device (100) to obtain a tissue biopsy specimen. The first button (228b) is operable to selectively apply a vacuum from the control module (500) to one or more portions of the biopsy device (100), such as the cutter lumen (136). is there. The rocker button (228a) is operable to selectively advance or retract the cutter (152), thereby opening and closing the side holes (118). As will be apparent to those skilled in the art in view of the teachings herein, the buttons (228a, 228b, 228c) may of course have other uses. In addition, an additional button (228) may be provided to provide additional functionality. For example, as described above, one such additional button (228) is a button that causes the conduit (402, 404, 406) and / or power cord (420) to retract into the vacuum control unit (500). Can be included. Additionally or alternatively, an indicator (not shown) may be included on the notched upper control unit (220) to provide visual feedback to the user. In a further configuration, the notched upper control unit (220) may be a resistive touch screen, capacitive touch screen, piezoelectric touch screen, acoustic pulse recognition, as will be apparent to those skilled in the art in view of the teachings herein. And / or a touch panel, such as any other type of touch screen.

  As previously mentioned, the latch member (238) engages the latch (190) to selectively couple the probe (102) to the holster (202). In this example, the latch member (238) fits into the gap (192) of the probe (102) best shown in FIG. 8, and latches (190) when the probe (102) slides over the holster (202). It is fixed by. When the probe (102) is to be disconnected, the latch (190) is pushed inward by the user so that the latch member (238) can exit the gap (192) past the latch (190). . The user can then disconnect the probe (102) from the holster (202).

  The top cover (210) further includes a proximal end (212), the proximal end (212) extending proximally from the proximal end (212), and the specimen holder teeth (214) and pegs (216). ). The specimen holder teeth (214) rotate the rotatable manifold (310) of the tissue specimen holder (302) and rotate the plurality of tissue specimen chambers, as discussed in more detail below, to rotate the cutter lumen (136). ) To be aligned. The peg (216) is operable to disconnect a parking pawl (not shown) when the probe (102) is coupled to the holster (202). Specimen holder teeth (214) and pegs (216) are disclosed in US Pat. , 938,786, and / or at least part of the teachings of US Non-Provisional Patent Application No. 13 / 205,189, filed August 8, 2011 under the name “Access Chamber and Markers for Biopsy Device”. Can be further constructed and / or configured.

  Further configurations of the top cover (210) of the holster (202) will be apparent to those skilled in the art in view of the teachings herein.

  5-6 depict the holster (202) with the top cover (210) removed, showing the components (270, 280, 288) housed within the housing base (260). In this example, holster (202) includes a cutter drive motor (270), a specimen holder motor (280), and a controller (288). In this embodiment, the cutter drive motor (270) is connected to the holster gear (272), and the upper portion of the holster gear (272) extends from the upper cover (210) through the gear hole (250). Cutter drive motor (270) is operable to engage and drive cutter actuation assembly (150) within probe (102), as discussed in more detail below. In this embodiment, the cutter drive motor (270) includes one or more rubber bushings (274) and / or rubber gaskets (276) to isolate vibration from the cutter drive motor (270). A sample holder motor (280) is coupled to the sample holder teeth (214) and is operable to transmit an encoder assembly (282) to transmit the rotational position of the sample holder teeth (214) to the controller (288). Including. The controller (288) of this embodiment is electrically connected to the cutter drive motor (270), the specimen holder motor (280), the encoder assembly (282), the control panel (226), and the control module (500). . The controller (288) may include a cutter drive motor (270) and / or responsive to one or more control or input signals from the encoder assembly (282), control panel (226), and control module (500). It is operable to output a control signal to the specimen holder motor (280). Controller (288) is disclosed in US Pat. No. 7,938,786 issued May 10, 2011 under the name “Vacuum Timing Algorithm for Biopsy Device”, the disclosure of which is incorporated herein by reference; US Patent Application Publication No. 2010/0317997 published on December 16, 2010 under the name “Biopsy Device with Reusable Portion”; filed on November 24, 2010 under the name “Handheld Biopsy Device with Needle Firing” US Non-Provisional Patent Application No. 12 / 953,715; and / or US Non-Provisional Patent Application No. 13 / 086,567 filed April 14, 2011 under the name “Biopsy Device with Motorized Needle Firing”. It can be further constructed or configured according to at least some of the teachings.

  Additional structures and / or configurations of holster (202) will be apparent to those skilled in the art in view of the teachings herein.

III. Exemplary Probe FIGS. 2-3 and 7-9 depict an exemplary probe (102) configured to be coupled to the holster (202) described above. The probe (102) of this example includes a probe body (104), a needle (110) extending distally from the probe body (104), and a tissue sample removably coupled to the proximal end of the probe (102). A holder (302) is included. The probe body (104) of this example includes a biocompatible and rigid plastic material, such as polycarbonate, which is divided into a chassis portion and an upper probe cover, but this is merely an option. Indeed, in some versions, the probe body (104) may be of unitary construction. As shown in FIGS. 3 and 7, the probe body (104) includes a main portion (106) and a distal probe portion (120). The main portion (106) includes an intermediate slot (108) configured to slide over the intermediate rail (240) of the top cover (210), as described above. Although the latch (190) of this embodiment is integrally formed as part of the main portion (106), this is merely an option and the latch (190) is mechanically coupled to the main portion (106). Separate components may be included. As best shown in FIG. 8, the latch (190) allows the gap (192) to receive the latch member (238) of the holster (202) when the probe (102) is coupled to the holster (202). To be molded. The first indicator (194) also indicates to the user that the first step, sliding the probe (102) to the side, to connect the probe (102) to the holster (202), Included on the main body (106). Of course, still other configurations and / or structures of the main portion (106) and / or the latch (190) will be apparent to those skilled in the art in view of the teachings herein.

  The distal probe portion (120) of this example extends from the main portion (106) and includes a top surface (122), a side surface (124), an outer surface (126), and a forward slot (128). The top surface (122) and side surface (124) of this embodiment are formed substantially perpendicular to each other, with the distal probe portion (120) extending below the overhang (222) and upward (224). ) Is sized to fit next to Thus, as can be seen in FIG. 2, the side surface (124) is adjacent to the upwardly extending portion (224) and the top surface (122) is surrounded by the overhang (222). In this example, the top surface (122) includes a second indicator (123), which is a second step, probe, for assembling the probe (102) with the holster (202). The user is instructed to slide in the length direction. The outer surface (126) of the present example provides a smooth transition from the distal probe portion (120) to the notched upper control unit (220) when the probe (102) is coupled to the holster (202). This is simply an option.

  Needle (110) is secured within probe body (104) by manifold (140), shown in FIG. 8, and extends distally therefrom. Needle (110) terminates in a blade assembly (350) coupled to a distal end (130) of needle (110). In this example, the needle (110) comprises an oval tube (112) having a notch (114) formed at the distal end thereof and an inset (116). Includes an ovular two-piece needle. The notch (114) is sized to receive the inset (116), and the inset (116) and the oval tube (112) are at the same height and length at the distal end (130). A two tiered needle is formed having a directional lumen (132) and a lateral lumen (134). In this example, the inset (116) includes a cylindrical tube having a plurality of openings (119) formed in the sidewall of the inset (116). In view of the teachings herein, the opening (119) allows fluid communication between the lateral lumen (134) and the longitudinal lumen (132), as will be apparent to those skilled in the art. It becomes. The needle (110) is in accordance with at least some of the teachings of US Non-Provisional Patent Application No. 13 / 150,950 filed June 1, 2011 under the name "Needle Assembly and Blade Assembly for Biopsy Device" And / or can be further constructed in any other configuration as would be apparent to one of ordinary skill in the art in view of the teachings herein.

  The manifold (140) of the present example receives the needle (110) in an oval hole formed in the manifold (140) and secures the needle (110) within the distal probe portion (120). Fix it. While this example depicts a manifold (140) that secures the needle (110) within the distal probe portion (120), the manifold (140) may be secured anywhere within the probe (102). I want you to understand. The manifold (140) further includes a plurality of hexagonal tabs (142) and square tabs (144) to securely secure the manifold (140) within the distal probe portion (120). The hexagonal tab (142) includes a hexagonal protrusion (not shown) that extends from the hexagonal tab (142) and is a complementary hexagon formed on the distal probe portion (120). The portion that is configured to be inserted into the shaped recess and from which the hexagonal protrusion extends rests on a framework within the distal probe portion (120). Square tab (144) is inserted into a square recess formed in distal probe portion (120). Thus, the hexagonal tab (142) and the square tab (144) cooperate to secure the manifold (140) within the distal probe portion (120). This implementation allows the manifold (140) to substantially secure the needle (110) to the probe body (104) and the longer needle can be used with the biopsy device (100) because of the fixation provided by the manifold (140). It should be understood from the examples. Of course, it should be understood that manifold (140), hexagonal tab (142), and square tab (144) are merely optional. By way of example only, tabs other than hexagonal tabs (142) and / or square tabs (144) may be used, or in some versions, manifold (140) is integral with distal probe portion (120). The tabs (142, 144) may be omitted entirely. Further configurations of the manifold (140) will be apparent to those skilled in the art in view of the teachings herein.

  In the embodiment shown in FIGS. 8-9, a fluid junction member (146) is coupled to the proximal end of the manifold (140) to connect the side lumen (134) to the conduit described above. Fluidly connect to one or more of (400). The fluid junction (146) is substantially sealed at the proximal end by the distal seal cylinder (156) of the cutter overmold (154), as described below. The cutter (152) is inserted into the inset (116), and the longitudinal lumen (132) is substantially in fluid communication with and sealed with the cutter (152) and the cutter lumen (136). Thus, the portion of the ovoid tube (112) that extends proximally from the inset (116) fluidly connects the side lumen (134) to the manifold (140) and the fluid confluence member (146). As can be seen in FIGS. 8-9, the fluid junction (146) includes a Y-joint that connects the fluid junction (146) to the inlet tube (196) and the inlet tube (196). Are then coupled to one or more of the conduits (400) described above. By way of example only, the inlet tube (196) may provide a vacuum source, a saline source, and / or an atmospheric supply to selectively supply vacuum, saline, and / or atmosphere through the side lumen (134). It can be selectively fluidly coupled to an atmospheric source. Such selective supply of vacuum, saline, and / or atmosphere may be achieved by the control module (500) and / or other valves, as will be apparent to those skilled in the art in view of the teachings herein. It can be controlled through the assembly. Of course, other valve assemblies and / or vacuum systems are disclosed in US Pat. No. 7,854,706 issued Dec. 1, 2010 under the name “Clutch and Valving System for Tetherless Biopsy Device”; “Vacuum Timing”. Such as those disclosed in US Pat. No. 7,938,786 issued May 10, 2011 under the name of “Algorithm for Biopsy Device”; and / or others.

  As previously described, cutter (152) is inserted into inset (116) to fluidly connect cutter lumen (136) with longitudinal lumen (132). The proximal end (168) of the cutter (152) is also fluidly connected to the connector tube (182) of the tissue specimen holder seal (180), as described below, so that the tissue is in the longitudinal lumen ( 132) provides a fluid passage that travels from the tissue specimen holder (302). In this example, the cutter (152) is an elongated tube having a polished distal end operable to cut tissue as the cutter (152) advances distally within the inset (116). Includes members. Thus, as tissue escapes into the side hole (118) (eg, by applying a vacuum through the side lumen (134)), the cutter (152) is advanced by the cutter actuation assembly (150), The tissue can be cut. Next, a vacuum is applied through the tissue specimen holder (302) to bring tissue proximally through the cutter lumen (136) and into the specimen holder of the tissue specimen tray (306) (shown in FIGS. 2 and 7). Can be pulled. Thus, tissue can be taken from a location proximate to the lateral hole (118) and deposited within the tissue specimen holder (302). Of course, the tissue may be deposited elsewhere, as will be apparent to those skilled in the art in view of the teachings herein.

  The cutter (152) of this example includes a cutter overmold (154) that is operable to rotate and translate the cutter (152) within the needle (110). In this example, the cutter overmold (154) is formed from a plastic molded around the cutter (152) to secure the cutter overmold (154) to the cutter (152), but is optional. Other suitable materials can be used and the cutter overmold (154) can be used against the cutter (152) using any other suitable structure or technique (eg, a set screw or the like). Can be fixed. The cutter overmold (154) includes a distal seal cylinder (156), a hexagonal proximal end (158), and a thread (159) placed therebetween. As previously described, the distal seal cylinder (156) is inserted into the fluid junction (146) to fluid-tighten the proximal end of the fluid junction (146). In some versions, an o-ring (not shown) or other gasket (not shown) is disposed around the distal seal cylinder (156) to place the fluid merge (146) at the proximal end. Can help seal. Of course, other configurations of the distal seal cylinder (156) and / or components for sealing the proximal end of the fluid junction (146) will be apparent to those skilled in the art in view of the teachings herein. Will be clear.

  The thread (159) of the cutter overmold (154) is configured to engage with and be screwed into the female thread (166) of the nut member (160). In this embodiment, the nut member (160) is firmly fixed to the probe (102), and the thread (159) and the internal thread (166) are engaged by the rotation of the cutter (152), The cutter (152) is advanced or retracted longitudinally relative to the needle (110) and probe (102). For example, as shown in FIGS. 8-9, the nut member (160) includes a square distal end (162) and a square proximal end (164), each of which is a nut member (160). To the probe (102) and the nut member (160) does not rotate or translate relative to the probe (102). Of course, it should be understood that in some versions, the nut member (160) may be integrally formed with or attached to the probe (102). By way of example only, the threads (159, 166) may be configured to have a pitch that provides about 40-50 threads per inch. Such a thread pitch may provide a ratio of cutter (152) rotation to cutter (152) translation that is ideal for cutting tissue. Alternatively, any other thread pitch may be used. Further configurations of the nut member (160) will be apparent to those skilled in the art in view of the teachings herein.

  The cutter overmold (154) is also configured to be inserted into and engage with a hexagonal recess (172) formed through the probe gear (170). ) Is also included. Thus, as the probe gear (170) rotates, the hexagonal proximal end (158) rotates. This rotation causes the thread (159) to engage the internal thread (166) of the nut member (160), thereby causing the cutter (152) to be proximal or distal depending on the direction of rotation of the probe gear (170). Is activated. As described above, the probe gear (170) extends from the bottom of the probe (102) and is configured to mesh with the holster gear (272). When the probe (102) is coupled to the holster (202), the cutter drive motor (270) described above is operated proximally or distally as the thread (159) passes through the nut member (160). It is operable to drive the cutter (152). The hexagonal end (158) allows the cutter (152) and cutter overmold (154) to translate longitudinally relative to the probe gear (170) while the probe gear (170) (152) and cutter overmold (154) are further configured to be still operable to rotate. Accordingly, the probe gear (170) remains engaged with the holster gear (272) while the cutter (152) and cutter overmold (154) are actuated longitudinally. Of course, the hexagonal proximal end (158) and the hexagonal recess (172) are only optional and engage with each other to transmit rotational motion, stars, teethed gears, square ones It should be understood that any other complementary component may be included, including triangular, etc.

  The tissue specimen holder (302) shown in FIG. 10 is coupled to the proximal end of the probe (102) and fluidly coupled to the cutter (152), the tissue specimen passing through the cutter lumen (136). It is transported proximally into the specimen holder (not shown) of the tray (306). Tissue specimen holder (302) is US Pat. No. 7,938,786 issued May 10, 2011 under the name “Vacuum Timing Algorithm for Biopsy Device”; U.S. Patent Application Publication No. 2008/0221480 published on Jan. 11; U.S. Non-Provisional Patent Application No. 13 / 205,189 filed Aug. 8, 2011 under the name "Access Chamber and Markers for Biopsy Device". Among the teachings of US Non-Provisional Patent Application No. 13 / 218,656 filed on August 26, 2011 under the name “Biopsy Device Tissue Sample Holder with Bulk Chamber and Pathology Chamber”; and / or others According to at least some of the above.

  The tissue sample holder (302) of this example includes a cover (304) that houses a rotatable manifold (310), and a plurality of tissue sample trays (306) are inserted into the rotatable manifold (310). . The rotatable manifold (310) includes a plurality of longitudinal chambers extending therethrough and disposed annularly around the rotatable manifold (310). Thus, each chamber can be selectively aligned with the cutter (152) and connector tube (182) described below, and tissue specimens can be transported from the side holes (118) into each chamber. Each chamber includes an upper longitudinal tray portion and a lower fluid portion that is parallel to and offset from the upper tray portion. An exemplary chamber is U.S. Patent Application Publication No. 2008/0221480 published September 11, 2008 in the name of "Biopsy Sample Storage", the disclosure of which is incorporated herein by reference; "Access Chamber and Illustrated and described in US Non-Provisional Patent Application No. 13 / 205,189, filed Aug. 8, 2011, under the name “Markers for Biopsy Device”. The tray portion is configured to receive a sample holder (308) of a tissue sample tray (306), and the sample holder (308) is configured to receive a cut tissue sample therein. Each specimen holder (308) of the tissue specimen tray (306) includes a floor, a pair of side walls, and a proximal wall that form a cavity configured to receive a tissue specimen. The floor, sidewall, and / or proximal wall includes a plurality of holes (not shown), and fluid flows from within each specimen holder (308) to a lower portion of a corresponding chamber formed in a rotatable manifold. Can be communicated to. When a vacuum is applied to the lower fluid portion, this vacuum is routed through the specimen holder (308), through the connector tube (182), into the cutter (152), and into the side holes (118). Thus, when a vacuum is applied, the cut tissue specimen is transported proximally into the corresponding specimen holder (308) by the vacuum. Of course, other configurations of the tissue specimen holder (302) will be apparent to those skilled in the art in view of the teachings herein. In some versions, the tissue specimen tray (306) and / or specimen holder (308) has a high contrast color compared to the color of the tissue specimen, eg, green, red, blue, etc. The presence of a tissue sample within the tissue sample tray (306) can be visually detected. In the illustrated embodiment, a dedicated passage does not receive the specimen holder (308), and instead a plug (310) is provided to selectively seal the dedicated passage.

  Referring again to FIG. 9, the tissue specimen holder (302) is connected to the cutter (152) by a tissue specimen holder seal (180). The seal (180) is a proximal wall (184) formed as a cylindrical disk configured to seal the distal end of the tissue specimen holder (302) against the proximal end of the probe (102). )including. By way of example only, the proximal wall (184) can include a resilient silicon rubber disk, and the tissue specimen holder (302) is pressed against the resilient silicon rubber disk to provide a fluid tight seal. Can be formed. In some versions, the proximal wall (184) receives a rim of the tissue specimen holder (302) to further seal the tissue specimen holder (302) against the seal (180) and It may include an annular recess (not shown) sized to form an interference or compression fit. The tissue specimen holder seal (180) of the present example also includes a connector tube (182) that extends distally into the probe (102) and the proximal end of the cutter (152) ( 168). The connector tube (182) is integrally formed with the proximal wall (184) and includes an internal passage (183), and the proximal end (168) of the cutter (152) is inserted into the internal passage (183). Is done. In the illustrated embodiment, the connector tube (182) has a sufficient longitudinal length so that the cutter (152) is not disconnected from the connector tube (182) by the cutter actuating assembly (150). Actuate proximally and / or distally within the tube (182). In this example, the connector tube (182) is configured to be fluid tight with the proximal end (168) of the cutter (152). By way of example only, connector tube (182) may be sized to form an interference fit with the proximal end (168) of cutter (152). Additionally or alternatively, the connector tube (182) includes one or more internal seals (not shown), such as wiper seals, dome seals, dome-shaped wiper seals, etc. to cut the connector tube (182) into the cutter ( 152) can be fluidly coupled to the proximal end (168).

  The seal (180) also includes a hole (186) formed through the seal (180) to be fluidly connected to the outlet tube (189). In this example, the hole (186) is parallel to the connector tube (182) and offset from the connector tube (182). The hole (186) is configured to align with the lower portion of the corresponding chamber of the rotatable manifold (310) described above. Outlet tube (198) is inserted into hole (186) at a first end and connected to one or more conduits (400) at a second end to provide one or more holes (186). Fluidly connected to the conduit (400). For example, the outlet tube (198) may be connected to a vacuum source, and the vacuum is provided to the side hole (118) through the rotatable manifold (310), cutter (152). Additionally or alternatively, outlet tube (198) can be connected to a saline source to provide saline through cutter (152) to flush the system. Still further, the outlet tube (198) can be coupled to a drug delivery system to deliver drugs (eg, anti-inflammatory drugs, analgesics, etc.) from the lateral holes (118).

  A central opening (187) also extends through the seal (180) and is configured to allow the specimen holder gear (188) to extend through the central opening (187). . In some versions, the central opening (187) includes a seal (not shown), such as a wiper seal, dome seal, dome-shaped wiper seal, etc., to fluidize the specimen holder gear (188) and seal (180). Can be sealed. In this example, the specimen holder gear (188) is a rotatable manifold (such as a T-shaped mandrel) to rotate the rotatable manifold (310) as the specimen holder gear (188) rotates. 310). As described above, when the probe (102) is connected to the holster (202), the specimen holder motor (280) shown in FIG. 5 to FIG. 6 is formed between the specimen holder teeth (214) and the specimen holder gear (188). Engagement is operable to engage and rotate the rotatable manifold (310). Still other configurations of the tissue specimen holder seal (180) and / or specimen holder gear (188) will be apparent to those skilled in the art in view of the teachings herein.

IV. Exemplary Modes of Operation As described above, the user interface (526) of the control module (500) allows a user to adjust several modes of operation to selectively control the operation of the biopsy device (100). be able to. Exemplary modes of operation and interfaces are described in further detail below, but other matters will be apparent to those skilled in the art in view of the teachings herein. An additional exemplary mode of operation and interface is disclosed in U.S. Patent Application Publication No. 05/21/2009, published May 21, 2009, under the name "Graphical User Interface For Biopsy System Control Module," the disclosure of which is incorporated herein by reference. No. 2009/0131821 and U.S. Patent Application Publication No. 2009/0131820 published May 21, 2009 under the name “Icon-Based User Interface On Biopsy System Control Module”.

  FIG. 11 depicts a user interface (526) that includes a selection bar (527, 528, 529). Each selection bar (527, 528, 529) includes a mode of operation that can be selectively controlled by the user using icons (530, 534, 536, 540, 542, 546). A user can touch and select a selected icon on the screen of the user interface (526) to adjust and / or select an operating mode. Other suitable methods for adjusting and / or selecting operating modes, such as providing buttons or switches on the user interface (526) or remotely, will be apparent to those skilled in the art in view of the teachings herein. Will. Indicators (532, 538, 544) on the selection bar (527, 528, 529) display the current operating mode or the selected operating mode of the biopsy device (100).

  The cutter selection bar (527) allows the user to select various sequences of cutters (120). The cutter (120) is initially in the distal position and closes the lateral hole (112). The cutter (120) then retracts proximally to open at least a portion of the hole (112) and allow tissue to escape into the hole (112). After the tissue enters the hole (112), the cutter (120) is advanced to a distal position. As the cutter (120) advances distally, the cutter (120) cuts the tissue that has escaped into the hole (112) and closes the hole (112). The operation of the cutter (120) may be changed by the user. The cutter selection bar (527) includes a hole icon (530), a speed icon (534), and a hole indicator (532). The user can use the hole icon (530) to adjust the size of the hole (112) with the cutter (120) so that the hole (112) does not open more than a preselected size. The cutter (120) may not be retracted sufficiently proximal to obtain a tissue sample of relatively short length, to obtain a tissue sample that is relatively close to the surface of the patient's skin, or for other purposes. It may be desirable. The user can adjust this effective needle hole (112) by activating the hole icon (530). Each time the user activates the hole icon (530), the biopsy system (10) makes a corresponding adjustment to the active needle hole (112), for example through the control module (500). Such adjustment may be incremental, for example, to provide 50%, 75%, or 100% open holes (112), although other increments may be used. In addition, each time the user activates the hole icon (530), the cutter portion of the hole icon (530) moves relative to the needle portion of the hole icon (530). An arrow is shown above the cutter portion of the hole icon (530) to highlight the maximum proximal position of the cutter (120) selected by the user. A text display (eg, “Sm” for small holes (112), “Lg” for large holes (112), etc.) to further indicate the effective hole (112) size selected by the user. May be included.

  It may be desirable to change the speed of the cutter (120). The user uses the speed icon (534) to adjust the translation speed of the cutter (120) so that the cutter can be retracted proximally and advanced distally at a preselected speed. can do. The user can adjust the speed of the cutter (120) by activating the speed icon (534). Each time the user activates the speed icon (534), the biopsy system (10) adjusts the corresponding speed (e.g., higher or lower) to the speed of the cutter (120), e.g. )I do. Such adjustment may be incremental. Each time the user activates the speed icon (534), the arrow on the speed icon (534) can move relative to the hash mark to indicate the relative speed of the cutter (120). The cutter (120) can also remain in a proximal position so that a sufficient amount of tissue can escape into the hole (112). The time that the cutter (120) remains in the proximal position can be adjusted based on the speed of the selected cutter (120). As the speed of the cutter (120) increases, the time that the cutter (120) stays may decrease. As the speed of the cutter (120) decreases, the time that the cutter (120) stays may increase. The time that the cutter (120) stays can be adjusted simultaneously with the speed of the cutter (120) when the user activates the speed icon (534), or the time that the cutter (120) stays is As will be apparent to those skilled in the art based on the teachings herein, different icons, buttons, switches, etc. can be used to adjust the speed of the cutter (120) separately.

  The hole indicator (532) can also be provided on the screen of the user interface (526). As shown in FIG. 11, the hole indicator (532) includes an indication of the end of the needle (110) with a brightly lit cutter (120). The hole indicator (532) may indicate the current position of the cutter (120) within the needle (110). As shown in FIG. 11, hole indicator (532) shows cutter (120) in a fully distal position to close hole (112). As the cutter (120) retracts proximally, the hole indicator (532) can display the proximally retracted cutter (120) on the user interface (526). This allows the user to see the actual position of the cutter (120) and the speed of the cutter (120), and that the selected settings adjusted by the hole icon (530) and speed icon (534) are applied appropriately. You can be sure that it is.

  The manifold selection bar (528) allows the user to select various sequences for the tissue specimen holder (302). The manifold (310) of the tissue specimen holder (302) rotates after the tissue specimen has been acquired so that it can be viewed by the user before the user obtains the next tissue specimen. Can be configured to present. By way of example only, the tissue specimen may be drawn into the chamber of the manifold (310) that is at the 12 o'clock position when the tissue specimen is first acquired. The manifold (310) then rotates until the tissue specimen is in the 3 o'clock position, which allows the user to easily view the tissue specimen from the side of the biopsy device (100). Such rotation can occur substantially immediately after the tissue specimen is pulled relative to the manifold (310), or the biopsy system (10) can perform a period of time (eg, Wait to see if any user input occurs within 2 seconds), and then rotate the tissue specimen to the 3 o'clock position only if no user input is made within that period Can do. The rotational position of the manifold (310) may be maintained such that the tissue specimen is kept in the 3 o'clock position until some other user input is provided. The user can provide input indicating that he wishes to obtain another tissue specimen, and the biopsy system (10) rotates the manifold (310) to the next available chamber (eg, immediately before). The chamber immediately adjacent to the chamber containing the acquired tissue specimen can be aligned. As an alternative to waiting for user input, the tissue specimen may be kept in the 3 o'clock position for a period of time (eg, 5 seconds), regardless of whether the user provided input, and the manifold (310) is automatically To align the next available chamber with the cutter (120).

  The manifold selection bar (528) includes a manifold icon (536), an advance icon (540), and a manifold indicator (538). The user can use the manifold icon (536) to adjust the rotation of the manifold (310) to view the acquired tissue specimen, and the manifold (310) rotates to a predetermined position. Depending on the orientation of the user of the biopsy device (100) or where the user is located relative to the biopsy device (100), the manifold (310) is rotated to various positions for viewing the tissue specimen. It may be desirable to do so. The user can adjust the rotation of the manifold (310) to view the specimen by actuating the manifold icon (536). Each time the user activates the manifold icon (536), the biopsy system (10) makes corresponding adjustments to the rotation of the manifold (310), for example through the control module (500). Such adjustment may be incremental, for example to provide rotation in 90 ° increments, but other increments may be used. In addition, each time the user activates the manifold icon (536), the arrow on the manifold icon (536) indicates the corresponding 90 ° increment selected by the user to position the manifold (310) in the tissue observation position. Can be lit as shown.

  It may be desirable to select a predetermined chamber of the manifold (310) for carrying the acquired tissue specimen. The user can use the advance icon (540) to gradually rotate the manifold (310) directly into the adjacent chamber. Each time the user activates the advance icon (540), the biopsy system (10) makes a corresponding adjustment to the rotation of the manifold (310), for example through the control module (500). Such adjustment may be incremental to accommodate each chamber of the manifold (310), although other increments may be used. The manifold (310) may advance two or more chambers at time, for example, in 90 ° or 180 ° increments. Advance icon (540) includes an indication of the chamber of manifold (310), with the dot indicating the first chamber selected to receive the tissue specimen. Each time the user activates the advance icon (540), the dots rotate clockwise or counterclockwise to indicate the corresponding chamber of the manifold (310) selected by the user to receive the tissue specimen. be able to.

  As shown in FIG. 11, the manifold selection bar (528) includes a manifold indicator (538). Manifold indicator (538) includes an indication of the chamber of manifold (310). The shaded area covers the currently selected chamber of the manifold (310) that receives the tissue specimen. As the manifold (310) rotates, the other chambers rotate on the manifold indicator (538) below the shaded area. Each chamber of the manifold (310) may be numbered on the manifold (310) so that a particular chamber can be easily identified. Thus, a text display of the number of the selected chamber of the manifold (310) that receives the tissue specimen may be shown on the manifold indicator (538) and in the center of the manifold indicator (538).

  The vacuum selection bar (529) includes a level icon (542), a clear icon (546), and a level indicator (544). When the needle (110) is inserted into the patient with the cutter (120) in the distal position, a vacuum can be applied to the lateral lumen (134) and / or the longitudinal lumen (132). . With the vacuum applied as described above, the cutter (120) retracts proximally to open the hole (112), thereby allowing tissue to enter into the hole (112) under the influence of the vacuum described above. And escape. The cutter (120) can remain in the retracted position for a period of time to ensure sufficient escape of tissue. The cutter (120) may then be advanced distally so that the cutter (120) closes the hole (112) and the prolapsed tissue is cut and housed at least initially within the cutter lumen (136). When a vacuum is applied and transmitted through the cutter lumen (136), the cut tissue specimen can be pulled proximally through the cutter lumen (136) and into the selected chamber of the manifold (310). .

  It may be desirable to adjust the vacuum level applied to the biopsy device (100) depending on the characteristics (stiffness, thickness, etc.) of the tissue to be sampled. The user can adjust the vacuum level by activating the level icon (542). Each time the user activates the level icon (542), the biopsy system (10) makes a corresponding adjustment to the amount of vacuum applied to the biopsy device (100), for example through the control module (500). . Such adjustment may be incremental, for example, to provide a selected amount of increase or decrease relative to the amount of vacuum, but other increments may be used. The level icon (542) can include a set of ascending bars to indicate the vacuum level of the biopsy system (10). To adjust the vacuum level of the biopsy system (10), the user can activate the level icon (542). Each time the user activates the level icon (542), the vacuum level of the biopsy system (10) may increase incrementally. Such incremental increase can be indicated by illuminating an additional bar in the set of rising bars of the level icon (542). The number of bars lit in the level icon (542) can indicate the vacuum level of the biopsy system (10). If the user activates the level icon (542) when all the bars are lit (eg, this may indicate that the vacuum level is highest), the vacuum level can be greatly reduced to the lowest level, Only the first bar of the set of bars is lit. Thus, the user can repeat various incremental vacuum levels by repeatedly actuating the level icon (542).

  At some point during use of the biopsy device (100), the biopsy device (100) may show a sign that it is full of tissue or other debris. Such signatures will be apparent to those skilled in the art in view of the teachings herein. At such times, or at other times, it may be desirable to initiate a sequence that can remove such tissue or debris to improve the performance of the biopsy device (100). A remove icon (546) may be activated to initiate such a sequence. When the user activates the removal icon (546), the maximum amount of vacuum can be applied to the biopsy device (100) over a period of time. Other suitable removal methods (eg, translating the cutter back and forth, flowing saline, etc.) will be apparent to those skilled in the art based on the teachings herein.

  As shown in FIG. 11, the vacuum selection bar (529) includes a level indicator (544). The level indicator (544) includes a set of bars in order from low to high to indicate the actual vacuum level applied to the biopsy device (100). When a vacuum is applied to the biopsy device (100), the corresponding bar can be lit to indicate the level of vacuum applied to the biopsy device (100). Each rising bar indicates a vacuum level, with higher bar illumination corresponding to higher vacuum levels and lower bar illumination corresponding to lower vacuum levels. Thus, when an actual vacuum is applied to the biopsy device (100), a set of bars on the level indicator (544) illuminate to indicate to the user the level of vacuum applied to the biopsy device (100). Can show. Other suitable display methods will be apparent to those skilled in the art in view of the teachings herein.

IV. Exemplary Control Exemplary control for operating the biopsy system (10) is shown in FIG. Step (700) includes applying a vacuum to biopsy device (100). The control module (500) is activated to fluidly apply a vacuum to the side lumen (134) and / or the longitudinal lumen (132) at a pre-selected vacuum level by a level icon (542). obtain. In step (710), cutter (120) is retracted to a proximal position to open at least a portion of side hole (112). The cutter (120) is retracted to the proximal position preselected by the hole icon (530) at a speed preselected by the speed icon (534). The cutter (120) can be retracted while a vacuum is being generated for the biopsy device (100), or the cutter (120) after a vacuum has been generated to the desired level for the biopsy device (100). ) Can retreat. When the side hole (112) is opened to a predetermined position, the tissue can escape into the side hole (112). The cutter (120) can remain in the proximal position as shown in step (720) to allow a sufficient amount of tissue to escape into the lateral hole (112). Step (730) includes advancing the cutter (120) distally to close the side hole (112) at a speed preselected by the speed icon (534). As the cutter (120) advances distally, the prolapsed tissue in the side hole (112) is cut by the cutter (120) inside the needle (110). The cutter (120) optionally shakes by oscillating proximally and distally to ensure that the tissue is completely cut within the needle (110), as shown in step (740). (Dither) can. With the vacuum applied to the biopsy device (100) at a level preselected by the level icon (542), then in step (750), the cut tissue passes through the cutter lumen (136). And can be transported from the side hole (112) to the tissue specimen holder (302). Tissue specimens are deposited in the preselected chamber of manifold (310) by advance icon (540).

  The cycle time is measured by the time required to take a tissue specimen. The cycle begins when a vacuum is activated at step (700) and ends when a tissue sample is deposited in the tissue sample holder (302) after step (750). The size of the tissue sample can depend on the length of the cycle time at which the tissue sample is taken. The longer the cycle time, the larger the tissue sample can be taken, and the shorter the cycle time, the smaller the tissue sample. The size of the tissue specimen is determined by the translation and / or rotation speed of the cutter (120), the dwell time of the cutter (120), the amount of shaking performed by the cutter (120), and the vacuum pressure applied to the biopsy device (100). It may depend on the cycle time due to factors such as the amount, the length of time to transport the tissue from the side hole (112) to the tissue specimen holder (302), etc. Other suitable factors will be apparent to those skilled in the art in view of the teachings herein. It may be desirable to optimize cycle time and / or tissue specimen size by adjusting such cycle time factors as discussed below.

  FIG. 13 depicts an exemplary control of vacuum regulation for the biopsy device (100). The control shown in FIG. 13 is the same as the control shown in FIG. 12 except that the control of FIG. 13 has an additional step (832). Step (832) includes applying maximum vacuum adjustment to biopsy device (100) after advancing cutter (120) distally. As described above, the user can change the vacuum adjustment to the biopsy device (100) by the user interface (526) on the control module (500) to selectively increase or decrease the vacuum pressure. . When the user adjusts the vacuum pressure on the biopsy device (100) below the maximum available vacuum pressure, the cut tissue specimen is transported from the side hole (112) to the tissue specimen holder (302). The amount of time required to do so can be increased due to the lower amount of vacuum pressure applied to the biopsy device (100), thereby increasing cycle time. Step (832) is a vacuum pressure adjustment performed by the user using the user interface (526) to apply maximum vacuum pressure to the biopsy device (100) after the cutter (120) has been advanced distally. Overrides. By waiting for the maximum vacuum pressure to be applied after the cutter (120) has been advanced distally, the user can use the user interface (in order to allow tissue to escape into the lateral hole (112) at a selected level. 526), the vacuum pressure to the biopsy device (100) can still be selectively adjusted. Step (832) can also be performed after cutter (120) has trembled, as shown in step (840) when the trembling step is performed.

  The maximum available vacuum pressure may be determined by comparing the ambient pressure with the maximum pressure that can be generated by the control module (500). Ambient pressure is within the control module (500), on the biopsy device (100), or other suitable on the biopsy system (10) as would be apparent to one of ordinary skill in the art based on the teachings herein. It can be measured by a pressure sensor at the sensor location. The maximum pressure generated by the control module (500) can be determined by fully operating the vacuum source (510) until the vacuum level is at a substantially constant pressure. The pressure generated by the control module (500) may also be within the control module (500), on the biopsy device (100), or other suitable on the biopsy system (10) as will be apparent to those skilled in the art. It can be measured by a pressure sensor at the site. If the pressure remains substantially within a predetermined range for a predetermined time, the pressure can be substantially constant. When the pressure generated by the control module (500) reaches a substantially constant maximum pressure, the difference between the maximum pressure and the ambient pressure is determined for the maximum vacuum pressure available to the biopsy device (100). obtain. The maximum vacuum pressure can vary with ambient pressure and the like. The minimum amount of vacuum pressure can be determined by the minimum amount of vacuum pressure required to transport the tissue specimen through the cutter lumen (136) to the tissue specimen holder (302). If the determined maximum vacuum pressure is lower than the minimum amount of vacuum pressure required to transport tissue to the tissue specimen holder (302), the control can prevent the biopsy device (100) from being used.

  Another exemplary control of vacuum adjustment to the biopsy device (100) is shown in FIG. The control shown in FIG. 14 is similar to the control shown in FIG. 12 except that the actual vacuum pressure is measured as depicted in step (912). The actual vacuum pressure may be other in the control module (500), on the biopsy device (100), or on the biopsy system (10) as would be apparent to one of ordinary skill in the art based on the teachings herein. It can be measured by a pressure sensor at the appropriate sensor location. Various elements of the biopsy device (100) (eg, rotation and / or translation speed of the cutter (120), dwell time of the cutter (120), amount of shaking of the cutter (120), tissue specimen holder (302) The length of time to carry the tissue, etc.) can then be adjusted based on the measured vacuum pressure.

  Once the vacuum pressure is measured in step (912), the level of vacuum pressure can be classified. As shown in FIG. 14, the vacuum pressure can be classified into three levels, such as relatively low, relatively intermediate, and relatively high. Other suitable numbers of level categories and category types will be apparent to those skilled in the art based on the teachings herein. Based on this category, the biopsy system (10) can be adjusted from nominal settings preselected by the user. If the vacuum level is classified as relatively low, step (920) may be followed to dwell the cutter (120) for an increased time that exceeds the nominal time. The cutter (120) can then be advanced distally at a lower speed below the nominal speed as seen in step (930). Step (940) includes shaking the cutter (120) by an increased cycle amount that exceeds the nominal cycle amount. At relatively low vacuum pressures, the length of time to transport tissue from the side hole (112) to the tissue specimen holder (302) can be longer than the nominal transport time as depicted in step (950). Allowing the cutter (120) to pause for a long time, moving the cutter (120) forward at a reduced speed, shaking the cutter (120) an increased number of times, and allowing increased tissue delivery time This allows tissue to escape sufficiently into the side hole (112) and to be carried to the tissue holder (302) with a sufficient tissue specimen size at a relatively low vacuum pressure. Any one of the steps (920, 930, 940, 950) can be applied individually or in combination to optimize the desired tissue specimen size and cycle time at a relatively low vacuum pressure. Should be noted.

  After step (912), once the vacuum pressure is at a relatively nominal level, nominal or preselected settings can be used. The cutter (120) can remain in the proximal position for a nominal time, as shown in step (922). The cutter (120) can then be advanced distally at a nominal speed (step (932)) and can shake for a nominal cycle amount (step (942)). Tissue can be transported to the tissue specimen holder (302) within a nominal time. Any one of the steps (922, 932, 942, 952) may be applied individually or in combination to optimize the desired tissue specimen size and cycle time at a relatively intermediate vacuum pressure. Note that.

  If the vacuum pressure is categorized as relatively high, step (924) may be applied and this step may be applied for a reduced time or for a reduced time below the nominal cutter (120) dwell time. ) In the proximal position. Step (934) includes advancing the cutter (120) distally at an increased speed that exceeds the nominal advance speed. The amount of cycles that cause the cutter (120) to shake can be reduced below nominal, as shown in step (944). The amount of cycles that shake the cutter (120) can also be bypassed, as will be apparent to those skilled in the art based on the teachings herein. Tissue can be transported from the lateral hole (112) to the tissue specimen holder (302) within a reduced time, less than nominal, as seen in step (954). By pausing the cutter (120) for a reduced time, advancing the cutter (120) at an increased speed, reducing the cycle of shaking the cutter (120), and reducing the length of tissue delivery time The tissue can be fully evacuated into the side hole (112) and transported to the tissue specimen holder (302) with sufficient tissue specimen size, with relatively high vacuum pressure and less cycle time. . Any one of the steps (924, 934, 944, 954) can be applied individually or in combination to optimize the desired tissue specimen size and cycle time at a relatively high vacuum pressure. Please pay attention to.

  The vacuum pressure can be measured after step (910), or optionally after each step shown in FIG. If the vacuum pressure level varies between steps, the vacuum pressure is reclassified after any step of FIG. 14 and adjusts the control of the biopsy device (100) after each step or a selected number of steps. can do. As an illustrative example, if the vacuum pressure is measured in step (912) and classified as relatively high, step (924) is applied to pause cutter (120) for an increased amount of time. Can do. If the vacuum pressure is measured again after step (924), it can be reclassified as relatively intermediate and step (932) can be applied to advance the cutter (120) at nominal speed. . The vacuum pressure can be measured and / or reclassified after any selected process. Other suitable variations will be apparent to those skilled in the art in view of the teachings herein.

  Another exemplary control of the biopsy device (100) is depicted in FIG. The exemplary control shown in FIG. 15 is similar to the exemplary control of FIG. 14 except that maximum vacuum adjustment is applied after the side holes (112) are closed. Similar to the control of FIG. 14, in the control of FIG. Sort into one category. Other suitable numbers of level categories and category types will be apparent to those skilled in the art based on the teachings herein. As previously described, if the vacuum pressure is relatively low, the cutter (120) may remain in the proximal position for an increased time (step 1020) and / or the cutter (120) may be at a reduced speed. Can be advanced distally (step 1030). If the vacuum pressure is relatively intermediate, the cutter (120) can be paused for a nominal time (step 1022) and / or the cutter (120) can be advanced proximally at a nominal speed. (Step 1032). If the vacuum pressure is relatively high, the cutter (120) can remain in the proximal position for a reduced time (step 1024) and / or the cutter (120) is advanced distally at an increased speed. (Step 1034). Any one of the steps (1020, 1022, 1024, 1030, 1032, 1034) may be applied individually or in combination to optimize the desired tissue specimen size and cycle time.

  The vacuum pressure can be measured after step (1010), or optionally after each step shown in FIG. If the vacuum pressure level varies between steps, the vacuum pressure is reclassified after any step in FIG. 14 and controls the biopsy device (100) after each step or a selected number of steps. Can be adjusted. As an illustrative example, if the vacuum pressure is measured in step (1012) and classified as relatively high, step (1024) may be applied to pause cutter (120) for an increased amount of time. it can. If the vacuum pressure is remeasured after step (1024), it can be reclassified as being relatively intermediate and step (1032) can be applied to advance cutter (120) at nominal speed. . The vacuum pressure can be measured and / or reclassified after any selected process. Other suitable variations will be apparent to those skilled in the art in view of the teachings herein.

  Once the cutter (120) is advanced to the distal position to close the lateral hole (112) and cut the tissue, maximum vacuum adjustment may be applied to the biopsy device (100) (step (1040)). As described above, the user changes the vacuum adjustment for the biopsy device (100) by adjusting the user interface (526) on the control module (500) to selectively increase or decrease the vacuum pressure. Can do. If the user adjusts the vacuum pressure on the biopsy device (100) below the maximum available vacuum pressure, the cut tissue specimen is transported from the side hole (112) to the tissue specimen holder (302). The time required to do so can be increased because the amount of vacuum pressure applied to the biopsy device (100) is reduced, thus increasing the cycle time. Step (1040) is a vacuum pressure adjustment performed by the user using user interface (526) to apply maximum vacuum pressure to biopsy device (100) after cutter (120) has been advanced distally. Disable. With maximum vacuum pressure applied to the biopsy device (100), the shaking of the cutter (120) can be reduced or ignored (step 1044) and / or from the side hole (112) through the tissue specimen holder ( 302) a minimum time to transport the tissue may be applied (step 1050). Steps (1044) and (1050) can reduce cycle time and still allow the desired tissue specimen size. By waiting for the maximum vacuum pressure to be applied after the cutter (120) has been advanced distally, the user can still selectively adjust the vacuum pressure on the biopsy device (100) via the user interface (526). The tissue can then escape into the lateral hole (112) at a selected level. Any one of the steps (1044, 1050) may be applied individually or in combination to optimize the desired tissue specimen size and cycle time.

  Any patents, publications, or other disclosure materials that are said to be incorporated herein by reference may, in whole or in part, be existing definitions, statements, or It should be understood that it is incorporated herein only to the extent that it does not conflict with other disclosure materials. Accordingly, to the extent necessary, the disclosure expressly set forth herein shall supersede any conflicting material incorporated herein by reference. Any document or part thereof that is said to be incorporated herein by reference, but that contradicts the existing definitions, statements, or other disclosure material described herein, It is only incorporated to the extent that there is no discrepancy with the disclosure material.

  Embodiments of the present invention have application in conventional endoscopes and open surgical instrumentation, as well as in robot-assisted surgery.

  By way of example only, the embodiments described herein may be processed before surgery. First, a new or used instrument can be obtained and cleaned if necessary. The instrument can then be sterilized. In one sterilization technique, the instrument is placed in a closed and sealed container, such as a plastic or TYVEK bag. The container and instrument can then be placed in a radiation field that can penetrate the container, such as gamma radiation, x-rays, or high energy electrons. Radiation can kill bacteria on the instrument and in the container. The sterilized instrument can then be stored in a sterile container. The sealed container can keep the instrument sterile until it is opened in the medical facility. The device can also be sterilized using any other technique known in the art including, but not limited to, beta or gamma radiation, ethylene oxide, or steam.

  Embodiments of the devices disclosed herein can be reconditioned for reuse after at least one use. Reconditioning can include any combination of device disassembly steps followed by cleaning or replacement of specific parts and subsequent reassembly steps. In particular, embodiments of the devices disclosed herein may be disassembled such that any number of specific parts or portions of the devices are selectively replaced or removed in any combination. Can do. Once a particular part has been cleaned and / or replaced, the device embodiment can be reassembled for subsequent use at a reconditioning facility or by a surgical team immediately prior to a surgical procedure. Those skilled in the art will recognize that reconditioning of the device can utilize a variety of techniques for disassembly, cleaning / replacement, and reassembly. The use of such techniques and the resulting reconditioned device are all within the scope of this application.

  While various embodiments of the present invention have been illustrated and described, further modifications of the methods and systems described herein may be achieved by appropriate modifications by those skilled in the art without departing from the scope of the invention. Some of these potential modifications are mentioned, others will be apparent to those skilled in the art. For example, the above-described examples, embodiments, external shapes, materials, dimensions, ratios, processes, and the like are illustrative and not essential. Accordingly, the scope of the present invention should be considered in terms of the following claims and is understood not to be limited to the details of construction and operation shown and described herein and in the drawings.

Embodiment
(1) In a biopsy system including a biopsy device,
The biopsy device includes a probe, the probe comprising:
(A) a needle extending distally from the probe;
(B) a cutter capable of moving relative to the needle;
(C) a tissue specimen holder removably coupled to the proximal end of the probe;
Including
The biopsy system operates in cycles to apply a vacuum to the biopsy device, retract the cutter to a proximal position, advance the cutter to a distal position, and transport the specimen to the tissue specimen holder Is possible,
The biopsy system, wherein the biopsy system is configured to adjust a duration of the cycle of the biopsy system during the cycle of the biopsy system.
(2) In the biopsy system according to Embodiment 1,
The biopsy system is operable to measure the amount of vacuum applied to the biopsy device.
(3) In the biopsy system according to Embodiment 2,
The biopsy system is operable to selectively classify the measured vacuum pressure.
(4) In the biopsy system according to embodiment 3,
The biopsy system is operable to selectively classify the measured vacuum pressure as relatively low, relatively nominal, or relatively high.
(5) In the biopsy system according to embodiment 3,
The cutter is configured to remain in the proximal position;
The biopsy system adjusts a duration that the cutter is configured to remain in the proximal position during the cycle of the biopsy system based on the selected category of the vacuum pressure measured. A biopsy system that is operable.

(6) In the biopsy system according to embodiment 5,
The biopsy system is operable to increase a duration in which the cutter is configured to remain in the proximal position when the measured vacuum pressure is selectively classified as relatively low. Or
The biopsy system is operable to reduce a duration in which the cutter is configured to remain in the proximal position when the measured vacuum pressure is selectively classified as relatively high. There is a biopsy system.
(7) In the biopsy system according to Embodiment 3,
The biopsy system operates to adjust the speed at which the cutter translates from the proximal position to the distal position during the cycle of the biopsy system based on the selected category of the vacuum pressure. A biopsy system that is possible.
(8) In the biopsy system according to embodiment 7,
The biopsy system is operable to reduce the rate at which the cutter translates from the proximal position to the distal position when the measured vacuum pressure is selectively classified as relatively low. Or
The biopsy system is operable to increase the speed at which the cutter translates from the proximal position to the distal position when the measured vacuum pressure is selectively classified as relatively high. There is a biopsy system.
(9) In the biopsy system according to embodiment 3,
The cutter is operable to vibrate proximally and distally after advancement to the distal position;
The biopsy system is operable to adjust the amount of cutter vibration during the cycle of the biopsy system based on the selected category of the vacuum pressure.
(10) In the biopsy system according to embodiment 9,
The biopsy system is operable to increase the amount of cutter vibration when the measured vacuum pressure is selectively classified as relatively low, or
The biopsy system is operable to reduce the amount of cutter vibration when the measured vacuum pressure is selectively classified as relatively high.

(11) In the biopsy system according to embodiment 9,
The biopsy system is operable to ignore the amount of cutter vibration when the measured vacuum pressure is selectively classified as relatively high.
(12) In the biopsy system according to embodiment 3,
The biopsy system is operable to adjust a time for transporting the specimen to the tissue specimen holder during the cycle of the biopsy system based on the selected category of the vacuum pressure. Inspection system.
(13) In the biopsy system according to embodiment 12,
The biopsy system is operable to increase the time to transport the specimen to the tissue specimen holder if the measured vacuum pressure is selectively classified as relatively low, or
The biopsy system is operable to reduce time to transport the specimen to the tissue specimen holder if the measured vacuum pressure is selectively classified as relatively high .
(14) In the biopsy system according to embodiment 1,
The biopsy system is operable to increase the amount of vacuum applied to the biopsy device after the cutter has translated from the proximal position to the distal position.
(15) In the biopsy system according to embodiment 14,
The biopsy system is operable to adjust the amount of vacuum applied to the biopsy device to a maximum amount of vacuum after the cutter has translated from the proximal position to the distal position. Inspection system.

(16) In the biopsy device according to embodiment 15,
The biopsy system further includes an interface configured to selectively increase or decrease the vacuum applied to the biopsy device;
The biopsy device is operable to override a selected increase or decrease in vacuum by the interface when the amount of vacuum is adjusted to the maximum amount of vacuum.
(17) A method of operating a biopsy system, wherein the biopsy system includes a biopsy device, the biopsy device includes a probe, and the probe extends a needle distally from the probe, The biopsy system is operable to provide a vacuum to the biopsy device having a cutter movable relative to the needle and a tissue specimen holder removably coupled to the proximal end of the probe In the method,
(A) applying a selected amount of vacuum to the biopsy device;
(B) retracting the cutter to a proximal position;
(C) keeping the cutter in the proximal position;
(D) advancing the cutter to a distal position;
(E) applying a maximum vacuum to the biopsy device so as to disable the selected amount of vacuum;
Including a method.
(18) A method of operating a biopsy system, wherein the biopsy system includes a biopsy device, the biopsy device includes a probe, and the probe extends a needle distally from the probe, The biopsy system is operable to provide a vacuum to the biopsy device having a cutter movable relative to the needle and a tissue specimen holder removably coupled to the proximal end of the probe In the method,
(A) applying a selected amount of vacuum to the biopsy device;
(B) retracting the cutter to a proximal position;
(C) measuring the amount of vacuum applied to the biopsy device;
(D) classifying the measured amount of vacuum applied to the biopsy device;
(E) causing the cutter to remain in the proximal position for a time determined based on the classified amount of vacuum;
(F) advancing the cutter to a distal position at a speed determined based on the classified amount of vacuum;
Including a method.
(19) In the method according to embodiment 18,
The cutter is configured to vibrate proximally and distally after advancement to the distal position;
The method wherein the amount of vibration of the cutter is determined based on the classified amount of vacuum.
(20) In the method of embodiment 18,
Further comprising applying a maximum amount of vacuum after the cutter has been advanced to the distal position.

1 depicts a schematic diagram of an exemplary biopsy system. 1 depicts a perspective view of an exemplary biopsy device. FIG. 3 depicts a perspective view of the biopsy device of FIG. 2 and shows an exemplary probe separated from an exemplary holster. FIG. 4 depicts a rear perspective view of the holster of FIG. 3. FIG. 5 depicts a rear perspective view of the holster of FIG. 4 with the upper housing cover omitted. FIG. 6 is an exploded perspective view of the holster of FIG. 5. FIG. 4 is a perspective view of the probe of FIG. 3. FIG. 8 depicts a top view of the probe of FIG. 7 with the upper probe cover omitted. FIG. 9 is an exploded perspective view of the probe of FIG. 8. 1 depicts a perspective view of an exemplary tissue specimen holder. FIG. 3 depicts a front view of an exemplary user interface for the biopsy device of FIG. 2. FIG. 3 depicts an exemplary control flow chart for the biopsy device of FIG. Figure 3 depicts another exemplary control flow chart for the biopsy device of Figure 2; Figure 3 depicts another exemplary control flow chart for the biopsy device of Figure 2; Figure 3 depicts another exemplary control flow chart for the biopsy device of Figure 2;

Claims (20)

In biopsy systems including biopsy devices,
The biopsy device includes a probe, the probe comprising:
(A) a needle extending distally from the probe;
(B) a cutter capable of moving relative to the needle;
(C) a tissue specimen holder removably coupled to the proximal end of the probe;
Including
The biopsy system operates in cycles to apply a vacuum to the biopsy device, retract the cutter to a proximal position, advance the cutter to a distal position, and transport the specimen to the tissue specimen holder Is possible,
The biopsy system, wherein the biopsy system is configured to adjust a duration of the cycle of the biopsy system during the cycle of the biopsy system. The biopsy system according to claim 1,
The biopsy system is operable to measure the amount of vacuum applied to the biopsy device. The biopsy system according to claim 2,
The biopsy system is operable to selectively classify the measured vacuum pressure. The biopsy system according to claim 3,
The biopsy system is operable to selectively classify the measured vacuum pressure as relatively low, relatively nominal, or relatively high. The biopsy system according to claim 3,
The cutter is configured to remain in the proximal position;
The biopsy system adjusts a duration that the cutter is configured to remain in the proximal position during the cycle of the biopsy system based on the selected category of the vacuum pressure measured. A biopsy system that is operable. The biopsy system according to claim 5,
The biopsy system is operable to increase a duration in which the cutter is configured to remain in the proximal position when the measured vacuum pressure is selectively classified as relatively low. Or
The biopsy system is operable to reduce a duration in which the cutter is configured to remain in the proximal position when the measured vacuum pressure is selectively classified as relatively high. There is a biopsy system. The biopsy system according to claim 3,
The biopsy system operates to adjust the speed at which the cutter translates from the proximal position to the distal position during the cycle of the biopsy system based on the selected category of the vacuum pressure. A biopsy system that is possible. The biopsy system according to claim 7,
The biopsy system is operable to reduce the rate at which the cutter translates from the proximal position to the distal position when the measured vacuum pressure is selectively classified as relatively low. Or
The biopsy system is operable to increase the speed at which the cutter translates from the proximal position to the distal position when the measured vacuum pressure is selectively classified as relatively high. There is a biopsy system. The biopsy system according to claim 3,
The cutter is operable to vibrate proximally and distally after advancement to the distal position;
The biopsy system is operable to adjust the amount of cutter vibration during the cycle of the biopsy system based on the selected category of the vacuum pressure. The biopsy system according to claim 9,
The biopsy system is operable to increase the amount of cutter vibration when the measured vacuum pressure is selectively classified as relatively low, or
The biopsy system is operable to reduce the amount of cutter vibration when the measured vacuum pressure is selectively classified as relatively high. The biopsy system according to claim 9,
The biopsy system is operable to ignore the amount of cutter vibration when the measured vacuum pressure is selectively classified as relatively high. The biopsy system according to claim 3,
The biopsy system is operable to adjust a time for transporting the specimen to the tissue specimen holder during the cycle of the biopsy system based on the selected category of the vacuum pressure. Inspection system. The biopsy system according to claim 12,
The biopsy system is operable to increase the time to transport the specimen to the tissue specimen holder if the measured vacuum pressure is selectively classified as relatively low, or
The biopsy system is operable to reduce time to transport the specimen to the tissue specimen holder if the measured vacuum pressure is selectively classified as relatively high . The biopsy system according to claim 1,
The biopsy system is operable to increase the amount of vacuum applied to the biopsy device after the cutter has translated from the proximal position to the distal position. The biopsy system of claim 14,
The biopsy system is operable to adjust the amount of vacuum applied to the biopsy device to a maximum amount of vacuum after the cutter has translated from the proximal position to the distal position. Inspection system. The biopsy device according to claim 15,
The biopsy system further includes an interface configured to selectively increase or decrease the vacuum applied to the biopsy device;
The biopsy device is operable to override a selected increase or decrease in vacuum by the interface when the amount of vacuum is adjusted to the maximum amount of vacuum. A method of operating a biopsy system, the biopsy system including a biopsy device, the biopsy device including a probe, the probe extending distally from the probe, with respect to the needle And a tissue specimen holder removably coupled to the proximal end of the probe, the biopsy system is operable to provide a vacuum to the biopsy device. In the method
(A) applying a selected amount of vacuum to the biopsy device;
(B) retracting the cutter to a proximal position;
(C) keeping the cutter in the proximal position;
(D) advancing the cutter to a distal position;
(E) applying a maximum vacuum to the biopsy device so as to disable the selected amount of vacuum;
Including a method. A method of operating a biopsy system, the biopsy system including a biopsy device, the biopsy device including a probe, the probe extending distally from the probe, with respect to the needle And a tissue specimen holder removably coupled to the proximal end of the probe, the biopsy system is operable to provide a vacuum to the biopsy device. In the method
(A) applying a selected amount of vacuum to the biopsy device;
(B) retracting the cutter to a proximal position;
(C) measuring the amount of vacuum applied to the biopsy device;
(D) classifying the measured amount of vacuum applied to the biopsy device;
(E) causing the cutter to remain in the proximal position for a time determined based on the classified amount of vacuum;
(F) advancing the cutter to a distal position at a speed determined based on the classified amount of vacuum;
Including a method. The method of claim 18, wherein
The cutter is configured to vibrate proximally and distally after advancement to the distal position;
The method wherein the amount of vibration of the cutter is determined based on the classified amount of vacuum. The method of claim 18, wherein
Further comprising applying a maximum amount of vacuum after the cutter has been advanced to the distal position.

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